Medical Device Suppliers
Are you struggling to exchange ‘valid’ product data due to the growing set of diverse data standards from trading partners and regulatory authorities around the world?
The Market
Hospitals, GPOs and regulatory agencies are all demanding reliable product data from device manufacturers to ensure patient safety, reduce operational costs, and enhance the effectiveness of post‑market surveillance. As a result, global manufacturers now face the pressure, more than ever before, to deliver on their data quality and data syndication initiatives or suffer the consequences of non-compliance.
The Data Challenges
Trading partners and regulatory agencies all have their own data exchange standards such as different product attributes and data validation rules. The master data requirements for regulatory compliance are different to those needed for commercial compliance (i.e. procurement and supply chain).
Medical Device manufacturers struggle to implement an efficient, sustainable processes to exchange accurate and ‘validated’ product data with trading partners like GPOs and hospitals, while meeting the regulatory requirements for product identification, labeling, and traceability.
The Solution!
Innovit’s MDM, PIM, GDSN and UDI solutions are purpose-built to meet your global data syndication needs. Simplify the process of managing and exchanging product data with trading partners and regulators around the world with one globally scalable, certified and affordable solution for data compliance.
With over 20 years of international experience, we’ve helped 90+ medical device companies meet global data compliance requirements and submitted hundreds of thousands of product records to GDSN data pools and regulatory bodies, such as the FDA.
Partners in Healthcare
At Innovit, our commitment to the Healthcare industry is strengthened by our network of partners. We collaborate with fellow thought leaders, industry experts, regulatory agencies, data pools, and global data standards bodies to help you solve the most challenging problems surrounding master data management and data compliance. Our global partners include:
MedTech Europe, GS1 Global Healthcare, Atrify, USDM, HTG.
GDSN
1-click publication of product data to GDSN “out-of-the-box”.
EUDAMED
Submit regulatory UDI data for European MDR compliance.
GUDID
Submit UDI data for FDA compliance and .UDI compliance
Meeting the Challenges of new Device Regulations?
Case study introductions for Innovit’s Life Science customers.
